BEUDAMED
    FDA Enforcement Class II Terminated

    Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.

    Recall: Z-0534-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0534-2020
    Event ID
    84160
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nextremity Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 4, 2019
    Initiation Date
    October 9, 2019
    Classification Date
    November 22, 2019
    Termination Date
    June 24, 2020
    Address
    6210 N Buffalo St, Warsaw, IN, 46580, United States

    Description

    Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.

    Reason

    Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length

    Code Info

    Lot Number: M1151 UDI: 00817701022558

    Distribution

    US Nationwide distribution.

    Quantity

    49 units